AbbVie, FutureGen ink pact to develop Next-Generation Therapy for Inflammatory Bowel Disease

FG-M701 is a fully human monoclonal antibody targeting TL1A, a clinically validated target in IBD. FG-M701 is uniquely engineered with potential best-in-class functional characteristics compared to first-generation TL1A antibodies with the goal to drive greater efficacy and less frequent dosing as a therapy for IBD.

"The prevalence of IBD continues to increase, and many people living with ulcerative colitis and Crohn's disease do not respond to current therapies," said Jonathon Sedgwick, Ph.D., senior vice president and global head of discovery research, AbbVie. "AbbVie's mission to raise the standard of care includes the pursuit of transformative therapies that help more patients living with autoimmune diseases achieve remission. We look forward to our collaboration with FutureGen in advancing development of FG-M701 for the treatment of IBD."

"We are very pleased to partner with AbbVie, a world-leader in the development and commercialization of innovative inflammation and autoimmune therapies," said Zhaoyu Jin, Ph.D., founder and chief executive officer, FutureGen Biopharmaceutical (Beijing) Co., Ltd. "We believe that AbbVie is a great partner, with the ability to apply their expertise and global scale to realizing FG-M701's therapeutic potential and rapidly advancing this therapy for patients suffering from IBD. The collaboration with AbbVie also highlights FutureGen's ability to generate potential best-in-class product candidates with our proprietary Structure-based Targeted Evolution Platform (STEP) technology platform."

Under the terms of the agreement, AbbVie will receive an exclusive global license to develop, manufacture and commercialize FG-M701. FutureGen will receive $150 million in upfront and near-term milestone payments and will be eligible to receive up to an additional $1.56 billion in clinical development, regulatory and commercial milestones, as well as tiered royalties up to low-double digits on net sales.

FutureGen has developed the proprietary STEP by integrating structural biology, advanced antibody engineering, and AI technologies to enable highly efficient, rapid and high-throughput drug screening and optimization. FutureGen has utilized STEP to develop CLDN18.2 antibody-dependent cellular cytotoxicity (ADCC) enhanced antibody (FG-M108), a potential best-in-class product with excellent efficacy and superior safety in the first-line treatment of advanced G/GEJ and pancreatic cancer, currently in Phase 3. Additionally, FutureGen possesses several innovative multi-specific antibodies and antibody-drug conjugates (ADC) for immuno-oncology therapy, including a CD40-PDL1 bi-specific antibody in clinical stage.